Statute Details
- Title: Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019
- Act Code: HBRA2015-RG5
- Type: Subsidiary legislation (SL)
- Authorising Act: Human Biomedical Research Act 2015 (noted in the extract as “(Section 63)”)
- Key Provision: Section 2 — Exemption for tissue banking activities regulated under other legislation
- Original Citation: SL 704/2019 (1 November 2019)
- Current Version Reference: 2025 Revised Edition (2 June 2025); status shown as current as at 27 March 2026
- Commencement Date: Not stated in the provided extract
What Is This Legislation About?
The Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019 (“Tissue Banking Exemption Regulations”) create a targeted exemption from certain requirements in the Human Biomedical Research Act 2015 (“HBRA”). In practical terms, the Regulations recognise that some tissue banking activities are already regulated through other specialised legal regimes—namely infectious disease research, health product clinical trials, and medicinal product clinical trials. Where those other regimes apply, the HBRA’s specified tissue banking provisions may not need to apply as well.
The Regulations therefore operate as a “regulatory overlap” solution. They prevent duplication and reduce compliance burden for tissue banks and researchers who are conducting tissue banking activities exclusively for purposes that fall within the scope of other Acts. At the same time, the Regulations preserve HBRA oversight where tissue banking is not exclusively within the exempt categories—by requiring compliance with the HBRA provisions in those non-exempt circumstances.
Although the title refers to “Tissue Banking and Notification — Exemption,” the extract provided shows the operative mechanism in section 2: an exemption from HBRA sections 34 to 37 for certain tissue banking activities. The Regulations are short and focused, and their legal effect depends heavily on how the tissue banking activity is characterised (and whether it is “solely” for the exempt purposes).
What Are the Key Provisions?
1. The exemption from HBRA sections 34–37 (section 2(1)). The core rule is in section 2(1), which states that “Sections 34, 35, 36 and 37 of the Act do not apply” to an individual, body of persons, or tissue bank who conducts tissue banking activities “solely” for the entity’s own research or own clinical trial, provided the activity falls within one of three categories.
In other words, the exemption is not a general carve-out for all tissue banking. It is conditional on (i) the purpose of the tissue banking activity, (ii) the “solely” requirement, and (iii) the activity being conducted for the entity’s own research/clinical trial (rather than, for example, tissue banking for broader third-party use). The exemption is also limited to the specific HBRA provisions listed: sections 34, 35, 36 and 37.
2. Exempt category (a): national public health research under the Infectious Diseases Act 1976 (section 2(1)(a)). The first exempt category covers “national public health research as defined in and conducted in accordance with section 59A of the Infectious Diseases Act 1976.” This is a legally precise cross-reference. For practitioners, the key is that the tissue banking activity must be part of “national public health research” meeting the statutory definition and conducted in accordance with section 59A of the Infectious Diseases Act.
This matters because “national public health research” is not simply any infectious disease study. It must satisfy the Infectious Diseases Act’s framework. If the research is instead a general biomedical study not meeting the section 59A conditions, the exemption would likely fail, and HBRA sections 34–37 would apply.
3. Exempt category (b): clinical trials of health products under the Health Products Act 2007 (section 2(1)(b)). The second category covers “clinical trials of health products conducted in accordance with the Health Products Act 2007.” Again, the exemption is triggered only when the clinical trial is properly conducted under that Act. Practically, this means the tissue banking activity must be linked to health product clinical trials that comply with the Health Products Act’s regulatory requirements (including approvals/authorisation and trial conduct rules, as applicable).
4. Exempt category (c): clinical trials of medicinal products under the Medicines Act 1975 (section 2(1)(c)). The third category covers “clinical trials of medicinal products conducted in accordance with the Medicines Act 1975.” The same logic applies: the tissue banking activity must be for medicinal product clinical trials that are conducted in compliance with the Medicines Act regime.
5. The “solely” requirement and the “to avoid doubt” clarification (section 2(2)). Section 2(2) is critical for risk management. It clarifies that where the individual/body/tissue bank conducts tissue banking activities “concurrently with, or in addition to,” or where it is “not solely” for the purposes specified in paragraph (1), then the entity must comply with HBRA sections 34–37 “in relation to that activity.”
This provision prevents partial or opportunistic reliance on the exemption. If a tissue bank uses the same operational channel, resources, or collection process for both exempt and non-exempt purposes, the exemption may not apply to the non-exempt portion. The legal drafting suggests a functional approach: compliance is required “in relation to that activity,” implying that practitioners should separate exempt and non-exempt activities where possible, and document the purpose and scope of each tissue banking activity.
How Is This Legislation Structured?
The Regulations are structured as a short instrument with a citation provision and a single substantive operative section. Based on the extract:
Section 1 (Citation) identifies the Regulations by name.
Section 2 (Exemption for tissue banking activities regulated under other legislation) contains the exemption rule and the “to avoid doubt” clarification. There are no additional parts or sections shown in the extract, indicating the Regulations are designed to be narrowly targeted rather than a comprehensive regulatory framework.
Who Does This Legislation Apply To?
Section 2(1) applies to an “individual, body of persons or tissue bank” that conducts tissue banking activities. The exemption is therefore relevant to both natural persons (for example, a principal investigator or researcher acting in a personal capacity) and institutional actors (such as research organisations, corporate entities, or tissue banks).
The exemption is also purpose- and context-specific. It applies only where the tissue banking activity is conducted “solely for the purpose of the individual’s, body’s or tissue bank’s own research or own clinical trial” and falls within one of the three cross-referenced categories (national public health research under the Infectious Diseases Act; health product clinical trials under the Health Products Act; or medicinal product clinical trials under the Medicines Act). If tissue banking is conducted for other purposes, or if it is not solely for those purposes, section 2(2) requires compliance with HBRA sections 34–37 for the non-exempt activity.
Why Is This Legislation Important?
This legislation is important because it addresses a common compliance challenge in biomedical research: overlapping regulatory regimes. Tissue banking can be implicated in multiple legal frameworks depending on the nature of the research or trial. Without an exemption, entities might face duplicative obligations—potentially requiring parallel processes under the HBRA and under the Infectious Diseases Act, Health Products Act, or Medicines Act.
By carving out HBRA sections 34–37 for specified categories, the Regulations streamline compliance for tissue banking activities that are already regulated elsewhere. For practitioners, this can affect licensing/approval strategy, internal compliance workflows, and how consent, governance, and operational controls are documented.
However, the “solely” requirement and the section 2(2) clarification mean the exemption is not a blanket relief. The practical impact is that tissue banks and research sponsors must carefully map their activities to the statutory categories and ensure that exempt and non-exempt uses are properly distinguished. From a legal risk perspective, the most significant exposure is relying on the exemption while conducting mixed-purpose tissue banking without adequate separation or documentation.
In enforcement terms, the Regulations do not remove HBRA oversight entirely; they remove it only for the listed HBRA provisions and only for the exempt purposes. Where the exemption does not apply, HBRA sections 34–37 become mandatory. Accordingly, counsel should treat the exemption as a conditional compliance pathway rather than a general permissive rule.
Related Legislation
- Human Biomedical Research Act 2015 (HBRA) — particularly sections 34, 35, 36 and 37 (as referenced by the Regulations) and section 63 (authorising provision)
- Infectious Diseases Act 1976 — section 59A (national public health research framework)
- Health Products Act 2007 — clinical trials of health products
- Medicines Act 1975 — clinical trials of medicinal products
Source Documents
This article provides an overview of the Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.